Table 1 Patient demographics and clinical characteristics at enrolment into the UK named patient programme
Patients receiving ≥1 dose of trifluridine/tipiracil (n = 194) | Patients not commencing treatment (n = 56) | |
|---|---|---|
Age (years), median (IQR) | 63.0 (54.0–69.0) | 62.0 (54.8–69.0) |
Female, n (%) | 83 (43%) | 21 (38%) |
BMI (kg/m2), median (IQR) | 25.8 (22.7–29.6) | 26.0 (23.5–28.4) |
ECOG-PS, n (%) | ||
0 | 54 (28%) | 8 (14%) |
1 | 127 (65%) | 39 (70%) |
2 | 13 (7%) | 9 (16%) |
KRAS-mutation, n (%) | ||
Wild type | 89 (46%) | 25 (45%) |
Mutated | 74 (38%) | 25 (45%) |
Not known | 17 (9%) | 4 (7%) |
Not recorded | 14 (7%) | 2 (4%) |
Disease duration (months),a median (IQR) | 35.7 (18.7–54.7) | 33.4 (19.5–47.9) |
Time from diagnosis of metastatic disease | ||
< 18 months | 61 (31%) | 20 (36%) |
≥ 18 months | 133 (69%) | 36 (64%) |
Prior colorectal surgery (n, %) | ||
Yes | 143 (74%) | 36 (64%) |
No | 51 (26%) | 20 (36%) |
Neoadjuvant therapy (n, %) | ||
Yes | 4 (2%) | 1 (2%) |
No | 190 (98%) | 55 (98%) |
Adjuvant therapy (n, %) | ||
Yes | 75 (39%) | 16 (29%) |
No | 119 (61%) | 40 (71%) |
Number of prior lines of therapy for metastatic disease | ||
1 | 15 (8%) | 6 (11%) |
2 | 92 (47%) | 24 (43%) |
3 | 51 (26%) | 12 (21%) |
≥ 4 | 36 (19%) | 14 (25%) |
Prior therapies for metastatic disease | ||
Fluorouracil or capecitabine | 193 (99%) | 55 (98%) |
5-FU | 178 (92%) | 53 (95%) |
Capecitabine | 90 (46%) | 26 (46%) |
Oxaliplatin | 163 (84%) | 49 (88%) |
Irinotecan | 193 (99%) | 55 (98%) |
Bevacizumab | 88 (45%) | 20 (36%) |
Cetuximab | 65 (34%) | 17 (30%) |
Panitumumab | 10 (5%) | 2 (4%) |
Aflibercept | 30 (15%) | 9 (16%) |
Regorafenib | 9 (5%) | 1 (2%) |
Mitomycin or MMC | 21 (11%) | 4 (7%) |
Other | 26 (13%) | 9 (16%) |